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Comparing Morning and Evening Thyroid Medication for People with Underactive Thyroid

Efficacy and Safety of Evening versus Morning dose of Levothyroxine in patients with Primary Overt Hypothyroidism: A non-inferiority, randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089783
Enrollment
184
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E039- Hypothyroidism, unspecified

Interventions

Intervention1: Tablet Levothyroxine: Evening administration of the tablet, at a dose ranging from 1.5 to 1.8 mcg/kg/day, administered orally once daily, for a duration of 12 weeks. Control Interventio

Sponsors

Riya Ranjith Vaidyar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 18-60 years with newly diagnosed overt hypothyroidism. Willing to give informed, written consent.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women. Patients with history of gastrointestinal disorders (Inflammatory Bowel Disease, Coeliac disease, Lactose intolerance.) Patients with history of cardiovascular diseases like arrhythmia, heart failure.

Design outcomes

Primary

MeasureTime frame
Change in Serum TSH levels in both groups - Evening dose and morning dose.Timepoint: 6 weeks, 12 weeks—

Secondary

MeasureTime frame
Change in Free T3 (FT3) & Free T4 (FT4) levelsTimepoint: 6 weeks, 12 weeks;Body weight (kg) & BMI (kg/m )Timepoint: 6 weeks, 12 weeks;MMAS-8 Medication Adherence ScaleTimepoint: 6 weeks, 12 weeks—

Countries

India

Contacts

Public ContactRiya Ranjith Vaidyar

All India Institute of Medical Sciences Patna

drpramodkumar@aiimspatna.org9835659978

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026